Why Clinical Research Ethical Safeguards May Not Be Feasible for EBP

Ethics and Evidence-Based Research

Contemporary healthcare is characterized by the integration of evidence-based practice and clinical research to dispense quality healthcare. Both evidence-based practice and clinical research are based on ethical guidelines that regulate the conduct of health professionals across the entire field of nursing. The evidence-based practice encompasses the application of evidence to nursing practice to improve outcomes. However, evidence-based research is focused on generating evidence for nursing practice. Ethics is concerned with issues of right and wrong or good and bad in healthcare, and thus, regulates both evidence-based practice and clinical research. The universality of ethical principles regulating both evidence-based research and practice, such as informed consent, has resulted in several controversies that affect the efficacy and accuracy of both clinical research and practice.

Why Clinical Research Ethical Safeguards May Not Be Feasible for EBP

Several ethical safeguards designed to regulate clinical research may not be feasible for evidence-based practice or the implementation of evidence-based quality improvement initiatives (EBQI). Seven core ethical principles apply to clinical research: scientific value, informed consent, fair-subject selection, favorable risk-benefit ratio, respect for subjects, independent review, and scientific validity (Melnyk & Fineout-Overholt, 2018). The divergent ethical principles form the foundations on which clinical research is based in contemporary nursing practice. Though some of the seven core ethical principles of clinical research are relevant to both nursing and medical practice, the majority are not feasible and should not be extended to regulate the evidence-based practice. For example, the ethical principle of a favorable risk-benefit ratio does not apply appropriately to both clinical research and evidence-based practice (EBP) due to the varying nature of risks in both domains of nursing. Although both clinical research and evidence-based practice are committed to minimizing risks and maximizing gains, risks in research range from none to very high while in EBP, risks are very low (Melnyk & Fineout-Overholt, 2018). Thus, the ethical framework used to regulate risks in clinical research and EBP should be differentiated.

The dissonance between ethical safeguards regulating clinical research and EBP is also highlighted by both the principles of independent review and informed consent. Independent review is a fundamental ethical principle in clinical research that requires clinical research to be subjected to an independent research review board for verification (Beauchamp & Childress, 2012). The ethical principle aims to reduce the potential conflict of interests that normally arises in clinical research and prevent the exploitation of patients as research subjects, as what is best for the research project may not be the best for patients (Melnyk & Fineout-Overholt, 2018). In the clinical domain of EBP, experts believe that the ethical principle of independent review is limiting and unnecessary as clinical practice rigors provide minimal chances for patient exploitation (Melnyk & Fineout-Overholt, 2018). The ethical principle of informed consent forms the bedrock of clinical research, as participating in research is deemed voluntary. Therefore, every researcher has an ethical obligation to provide information on his or her research so that individuals can make informed decisions on participating in the research. In the sphere of EBP, the principle of informed consent falls within good clinical practice and is covered by a patient’s consent to clinical care (Melnyk & Fineout-Overholt, 2018). Thus, the principle of informed consent is inappropriate and serves as an impediment to smooth clinical practice.

Ethical Controversies Surrounding the Implementation of EBQI Initiatives

In modern-day clinical practice, the implementation of EBQI initiatives is characterized by ethical controversies. EBQI initiatives mainly focus on issues concerning quality assurance and audit in clinical practice as they are used to assess how well current EBPs compare with best practices available in the medical field. EBQI initiatives form the core of quality improvement (QI) in clinical practice and are designed to assure patients and health care providers of the dispensation of quality, systematic, and reliable health care (Melnyk & Fineout-Overholt, 2018). Quality improvement programs are systematic, data-guided activities designed to foster immediate improvements in healthcare delivery in particular settings (Melnyk & Fineout-Overholt, 2018). Therefore, both QI and EBQI initiatives are essential not only in the delivery of quality healthcare but also in the advancement of existing evidence-based practices.

Clinical ethical regulations are at the center of the troubles plaguing the implementation of EBQI projects in healthcare facilities. In chapter Two Ethical Exemplars, Melnyk and Fineout-Overholt (2018) assert that the controversies related to the implementation of EBQI activities are based on the conflicting definition of clinical research. The divergence in opinion on matters of clinical research and EBQI initiatives is worsened by the broad definition of research by the Office for Human Research Protection (OHRP). This has resulted in several research organizations being involved in studies, primarily carried out as QI, though deemed by the OHRP as clinical research, fined heavily. Ethical controversies related to the implementation of EBQI programs also arise in the domain of research publications. Most reputable medical research journals only publish research articles that are reviewed and authorized by an independent research body due to the fear of publishing disputable findings (Melnyk & Fineout-Overholt, 2018). This has resulted in most researchers conducting QI programs to pursue publication only after the completion of the projects, which also raises issues regarding the broader interests of their research. Another ethical controversy in the domain of EBQI programs is related to the role of research administrators who are tasked with classifying studies into research or QI initiatives. The currently confusing responsibility of administrators has added to the controversies plaguing the implementation of EBQI programs as inappropriate classification of studies could result in avoidance of ethical review or lead to their less intensive review.

The ethical controversies that characterize the implementation of EBQI programs are related to the four core ethical principles of beneficence, non-maleficence, autonomy, and justice. Both the broad definition of research by the OHRP and ethical controversy surrounding the publication of clinical research is a huge stumbling block in the advancement of EBPs and thus, an impediment in the dispensation of quality health care. The two issues, compounded by the huge fines imposed on organizations deemed to have violated ethical research principles, discourage the development of clinical studies. Therefore, this results in limited QI programs that adversely impact both beneficence and non-maleficence principles, which are aimed at doing good and limiting harm to patients, respectively. The confusing responsibility of administrators results in the poor conduct of study evaluations, which negatively affects both the principles of autonomy and justice. The ethical principles of autonomy and justice deal with patients’ informed consent and the fair distribution of clinical resources, respectively.

Ethical Principles in Conflict with Patients’ Role in Improving Healthcare

The ethical principles of beneficence and non-maleficence conflict with the concept of patients’ involvement in improving healthcare. The principle of beneficence conflicts with the idea of patients’ engagement in activities that are aimed at improving healthcare, such as clinical research. According to Melnyk and Fineout-Overholt (2018), the involvement of patients in research exposes them to manipulation as research subjects, which may, at times, contradict the ethical principles of beneficence as what is good for a research project may not be good for a patient. In a clinical research context, the potential exists for the exploitation of patients, and this is the main reason why all research activities are subjected to an independent review. The ethical principle of non-maleficence challenges the concept of patient engagement in research to improve the quality of healthcare. In clinical research, subjects are placed at the risk of harm for the good of others (Melnyk & Fineout-Overholt, 2018). Exposure of patients to harm for purposes of research, therefore, defeats the purpose of the ethical principle of non-maleficence in the first place.

The ethical principle of autonomy is a huge impediment to the concept of patients’ engagement in improving healthcare. The principle of autonomy holds that clinical research is voluntary, and therefore, a patient cannot be forced to engage in any study (Beauchamp & Childress, 2012). Moreover, for clinical research to be deemed legal, the participants involved have to give informed consent to the study in the first place. Patients’ autonomy is, therefore, a huge impediment to the improvement of healthcare as individuals rarely consent to participate in research studies. Thus, several essential studies that require human participation are not done in a timely and effective manner, which negatively affects the improvement of the quality of clinical care.

The various ethical principles that conflict with the concept of patient involvement in improving healthcare can be resolved through the harmonization of clinical research regulation frameworks. The root of ethical controversies that surround the concept of patient involvement in improving healthcare can be traced to the wide definition and scope of research. Clinical research should be differentiated from EBQI initiatives and QI programs to ensure that the ethical principles regulating nursing research and practice do not clash. Therefore, the harmonization of clinical research regulation frameworks will ensure that the scope and definition of research are well conceptualized to minimize the controversies currently occurring in clinical practice.

Conclusion

Ethical regulations are essential in both EBPs and clinical research as they ensure that these two domains of nursing are conducted legally and morally. However, ethical regulations also cause controversies plaguing both the practice of clinical research and EBPs, particularly, the implementation of EBPQI interventions. The use of similar ethical principles in the regulation of both clinical research and EBP is a huge cause of controversies. The two nursing fields should be regulated by a distinct set of ethical regulations and frameworks to minimize the constant disputes that emanate from the modern-day practice of clinical research and EBP in the field of nursing.

References

Beauchamp, T. L., & Childress, J. F. (2012). Principles of biomedical ethics (7th ed.). New York: Oxford University Press.

Melnyk, B. M., & Fineout-Overholt, E. (2018). Evidence-Based Practice in Nursing & Healthcare: A Guide to Best Practice. Lippincott Williams & Wilkins.